We need a Public Domain Day to highlight when drugs go off patent

ByPeter KolchinskyandJessica Sagers

February 14, 2019

Jack Taylor/Getty Images

This Jan. 1, readers, archivists, and creatives in the United States celebrated a special holiday: the largest Public Domain Day in 21 years. The legal ownership of hundreds of works of classic literature — this year including well-loved Robert Frost poems like “Nothing Gold Can Stay” and “Stopping by Woods on a Snowy Evening” — was transferred into the hands of the people.

We suggest a plot twist: Let’s celebrate the same way when drug patents expire.

Every year, patents on high-profile branded drugs expire and these compounds “go generic,” allowing competitors to make and sell these same treatments at lower prices. Unlike literature, where copyright protection can last a whopping 95 years or more after initial publication, most drugs are under patent protection for just 10 to 15 years. Companies that successfully bring a drug to market have only that time to charge high prices before the drug goes generic. Patent protection is their window to profit from their investments and to plow some of that money back into developing new treatments. This system of incentives keeps the biotechnology innovation engine churning, rather than allowing it to milk cash-cow drugs forever.

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In the arts world, from this year’s Public Domain Day on, all works of literature published for the first time in the United States in 1923 are now free for creators to innovate upon. New compilations of best-loved poems will be printed, with younger artists bringing a more diverse eye to introductions and illustrations. The opportunity to choose between multiple editions of classic texts will bring down prices, increasing accessibility.

Creative parodies, such as 2009’s “Pride and Prejudice and Zombies,” will abound. Film and television will incorporate relevant material. If you first heard Percy Shelley’s “Ozymandias” and Walt Whitman’s “When I Heard the Learn’d Astronomer” while watching “Breaking Bad,” you have the public domain to thank.

As the result of some complicated legislative history, Public Domain Day will now occur every Jan. 1 until 2073. After that, works published by authors who died 70 years earlier will enter the public domain each year. This means that every year from now on we will receive an open-access treasure trove of works published years earlier, free for readers and creators.

Public Domain Day is clearly something to celebrate. The expiration of a copyright on a literary work merits a moment to admire its beauty, contemplate our gratitude to its creator, and mark the place it has held and will continue to hold in our collective human story.

We should do the same when branded drugs enter the public domain. These therapies keep working just as well as before, but they become much less expensive. In the case of oral drugs, there’s an average 90 percent drop in price within a few years as multiple generics come into the market. By anticipating when a branded drug is set to enter the public domain and publicizing the date as it approaches, the public might not only show innovators that they are appreciated but also apply some healthy social pressure to let them go generic with grace, instead of tying up patent expirations in complicated legislative battles that delay the entry of generics. In short, we need a Public Domain Day for drugs.

Specific information on drug patent expirations is currently suspiciously difficult to find. A few websites, including GoodRx and Drug Patent Watch, compile lists of drugs that should, in theory, go generic within the next few years. But there is no definitive, trustworthy resource for the public to consult. The literary and artistic community has recognized this challenge and supports multiple international organizations such as Open Knowledge Foundation’s Working Group on the Public Domain and the Public Domain Review, as well as Twitter accounts (for example, @publicdomainday) to inform content producers and interested laypeople when copyright protections on popular works expire.

We propose that the biotech community develop similar resources, though we recognize that clear access to this information may be precluded by tangles of lawsuits and pay-for-delay settlements.

Creative Commons and the Internet Archive recently sponsored a public-domain-themed bash in San Francisco to celebrate Public Domain Day, featuring keynote speeches by Harvard and Berkeley intellectual property law professors accompanied by lightning talks and panels devoted to the newly available works. Our vision is to see a similar event in Cambridge, Mass., celebrating the drugs whose patent protections are set to expire this year, perhaps with their creators recounting stories about how they were developed, physicians giving their clinical perspectives, and patients sharing how these medications changed their lives.

The life cycle of a drug, from experimental molecule to branded drug to generic drug, is something to celebrate if allowed to run its course with integrity. On Public Domain Day, it might even be fair to mourn drugs for which companies have engaged in diabolical schemes to delay the entry of their inventions into the public domain without justification (which is to say that some delays are justified, such as when a drug is meaningfully improved).

Celebrating and upholding patent expiration dates is only a step toward a health care system that is cost-effective for society and affordably meets patient needs. But real progress is made one step at a time. Down the road we also need to eliminate or cap out-of-pocket costs to make drugs affordable to individuals.

In the newly quotable words of Robert Frost, “The woods are lovely, dark and deep. / But I have promises to keep, / And miles to go before I sleep, / And miles to go before I sleep.”

Peter Kolchinsky is a managing partner of RA Capital Management LLC and author of the Biotech Social Contract series on Medium. Jessica Sagers is a Ph.D. student in auditory neuroscience at Harvard University and an intern at RA Capital Management LLC.